Lead Electrical Engineer I

Job Summary


Responsibilities

• Lead Electrical design and validation of high-density, multi-layer PCBs with analog/digital/mixed-signal circuits of Beckman Coulter Diagnostics new, on-market products and microcontroller-based subsystems.
• Design high-precision hardware platforms within the regulated medical device domain, gaining deep exposure to cutting-edge laboratory diagnostic instruments and complex fluidics-hardware interfaces, while driving root cause analysis and corrective actions for product issues.
• Own hardware development of power management, signal conditioning, and microcontroller-based subsystems from concept to release, including architecture, design verification, and risk mitigation.
• Ensure hardware designs comply with IEC 60601, ISO 13485, and FDA Class I/II requirements by coordinating external safety and EMC testing and driving design updates based on test results.
• Collaborate with cross function teams to resolve manufacturing and field issues, conduct feasibility studies, risk assessments, and design reviews and validate designs through analysis and testing.

Requirements

• B.E./B.Tech and M.E./M.Tech in Electrical/Electronics Engineering with 8+ years of experience in medical or industrial-grade PCB hardware development.
• Strong expertise in electronic system and circuit design, EDA Tools (OrCAD, Altium, PADS, PSpice, LTspice, or equivalent), IEC/FDA medical device regulations, EMI/EMC standards and mitigation strategies.
• Masterful use of advanced lab equipment, including high-bandwidth oscilloscopes, spectrum analyzers, logic analyzers, and active loads.
• Lead the technical investigation for critical field failures, manufacturing escapes, and design defects. Own the end-to-end CAPA (Corrective and Preventive Actions) pipeline-utilizing structured problem-solving frameworks (like 8D, 5-Whys, or Fishbone analysis) to isolate failure modes, deploy immediate containment, and implement permanent design or procedural fixes across global product lines.
• Proven expertise in product lifecycle management, regulatory documentation, technical troubleshooting, and cross-functional leadership, with the ability to clearly communicate complex hardware concepts to software teams and non-technical stakeholders.

Preferred Qualifications

• Experience in medical device design and development, preferably within IVD instrumentation, with advanced certification in Electrical CAD/EDA tools being an added advantage.
• Experience in multi-layer PCB layout design, including component placement, trace routing, and applying DFM/DFA guidelines for seamless manufacturing.
• Exposure to medical device design processes and quality systems. Exposure to BOM PCB Manufacturing techniques and Strong PCB Vendor communication skills
• Experience on Six Sigma (or equivalent DFSS / DMAIC) methodologies to implement systematic design controls to maximize yield and ensure long-term product reliability.

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